Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Ventilation strategy

Detailed Description

Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients coming in for cardiac surgical procedures will be recruited into the study.
• Both men and women will be recruited into the study.
• All patients over the age of 18 will be recruited into the study.
• Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.

Exclusion Criteria:

• Patients with preexisting respiratory failure and active infection will be excluded from the study.
• Patients undergoing one lung ventilation during surgery will be excluded from the study.
• Patients undergoing emergency cardiac surgery will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low tidal volume arm	Other: Ventilation strategy
Active Comparator: Conventional tidal volume arm	Other: Ventilation strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to extubation	the time patient was extubated in the ICU

Secondary Outcome Measures

Outcome Measure	Time Frame
Oxygenation at 4 hours, 8 hours, 12 hours and 24 hours post surgery.	measurement of blood gas at 4, 8 , 12 and 24 hours post surgery

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Study Director: Daniel Talmor, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 30, 2007
• First Submitted That Met QC Criteria: October 1, 2007
• First Posted (Estimate): October 2, 2007

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: cardiac surgery; Acute lung injury; The incidence of ARDS after elective cardiac surgery is 1-3%; The impairment of lung function and oxygenation may occur in 20-80% of patients undergoing surgery.; The purpose of this study is to assess the efficacy of low tidal volume ventilation.; Reducing interleukin and cytokine production may prevent or reduce the incidence of acute lung injury.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: 2007P000113